PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH)

• Status: Terminated
• Trial end date: 2020-08-05
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter double-blind, placebo-controlled study to evaluate the safety, efficacy and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to 80 years of age with PAH.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Complexa, Inc.
• Collaborators: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute); Cardiovascular Clinical Science Foundation; Clinical Works; Innovative Analytics; Medpace, Inc.; MicroConstants; Philips Healthcare
• Treatments: CXA-10

Criteria

Inclusion Criteria:

• Males and females between 18 to 80 years of age inclusive at Screening

• Weight ≥40 kg

• Must have a diagnosis of WHO Group 1 PH

• Have a World Health Organization (WHO) Classification of Functional Status Class II or III of patients with PH

• Must meet hemodynamic criteria by means of a right heart catheterization

• Meet pulmonary function test parameters

• A 6 MWD test of ≥125m and ≤550m at the visit

• Subjects must have a resting arterial oxygen saturation (SaO2) ≥90%, with or without supplemental oxygen, as measured by pulse oximetry at Screening

• Subjects enrolled in a prescribed exercise program for pulmonary rehabilitation must be in a stable program for 3 months prior to Screening (Visit 1) and must agree to maintain their current level of rehabilitation throughout the study. If subjects are not enrolled in a prescribed exercise training program for pulmonary rehabilitation, they cannot enroll during the Screening/Baseline Period or throughout the study

• If receiving simvastatin-containing products: dose should not exceed 20 mg/day

• Subjects must be receiving no more than three of the following previously approved PAH therapies: phosphodiesterase type 5 (PDE-5) inhibitors, endothelin receptor antagonist (ERA), soluble guanylate cyclase (sGC) stimulator, prostanoids, prostacyclin receptor agonists and must be on stable doses (≥3 months) at Screening (Visit 1)

Exclusion Criteria:

• Contraindications for CMRI imaging

• WHO Groups 2, 3, 4 and 5 Pulmonary Hypertension

• Unrepaired congenital heart defects and significant congenital heart defects (i.e., atrial septal defects, ventricular septal defects, and patent ductus arteriosus) repaired less than 1 year prior to Screening (Visit 1) (Group 1 classification of Pulmonary Hypertension)

• QTcF > 500 msec

• Acute myocardial infarction or acute coronary syndrome within the last 90 days

• Cerebrovascular accident/transient ischemic attack (CVA/TIA) within the last 90 days

• Hospitalization for left heart failure within the last 90 days

• Clinically significant aortic or mitral valve disease defined as greater than mild regurgitation or mild stenosis; pericardial constriction; restrictive or constrictive cardiomyopathy; left ventricular dysfunction (LVEF < 50%); left ventricular outflow obstruction; symptomatic coronary artery disease; autonomic hypotension; or fluid depletion

• Chronic atrial fibrillation and life-threatening cardiac arrhythmias

• Personal or family history of congenital prolonged QTc syndrome or sudden or sudden unexpected death due to a cardiac reason

• Clinically significant anemia

• Severe hepatic impairment or active chronic hepatitis

• Receiving intravenous inotropes within 2 weeks prior to Screening

• History of angina pectoris or other condition that was treated with long or short acting nitrates <12 weeks of Screening

• Received prednisone doses >15mg/day or changes in immunosuppressive medications < 12 weeks prior to Screening (Visit 1)

• Recent (within 1 year) history of abusing alcohol or illicit drugs.

• History of any primary malignancy, with no evidence of disease for at least 5 years

• Treatment with any investigational drug or device within 30 days or 5 half-lives